Patient-specific positioning guide: A 3D-printed positioning guide designed through virtual surgical planning to assist in the accurate reduction of ZMC fractures.
Customized titanium plate: A custom-fabricated titanium plate designed to fit the patient's specific anatomy for rigid fixation of ZMC fractures.
Study summary
The goal of this clinical trial is to evaluate the accuracy and stability of positioning guides and customized titanium plates in the treatment of Zygomaticomaxillary Complex (ZMC) fractures. The main questions it aims to answer are:
* Is the anatomical reduction achieved using a virtual planning-based positioning guide accurate when compared to preoperative plans?
* Does the customized titanium plate provide stable fixation during the follow-up period?
Researchers will compare the actual postoperative outcome to the preoperative virtual surgical plan to see if the customized workflow improves anatomical alignment.
Participants will:
* Undergo a preoperative Computed Tomography (CT) scan for virtual surgical planning.
* Receive surgical treatment using a patient-specific positioning guide and customized titanium plate.
* Complete follow-up assessments including postoperative CT scans and clinical evaluations for 6 months.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients diagnosed with Zygomatico-maxillary complex fractures requiring surgical intervention.
* Patients aged 18 years or older.
* Patients willing to provide informed consent and comply with follow-up protocols.
* Patients with adequate bone quality and quantity for stable fixation.
Exclusion Criteria:
* Patients with comminuted ZMC fractures that preclude the use of custom-made guides based on mirroring the contra lateral side.
* Patients with pre-existing facial deformities or asymmetries that would interfere with accurate assessment of fracture reduction.
* Patients with systemic diseases or conditions that contraindicate elective surgery or impair bone healing (e.g., uncontrolled diabetes, severe osteoporosis, active malignancy, and immunosuppression).
* Patients on medications affecting bone metabolism (e.g., long-term corticosteroids, bisphosphonates). Patients with active infections in the maxillofacial region.
* Pregnant or lactating women.
* Patients with psychiatric disorders or unrealistic expectations.
* Patients who are unable to undergo CT scans or follow post-operative instructions.
Primary outcome measure(s)
Accuracy of Fracture Reduction — one week postoperative Evaluation of the accuracy of fracture reduction achieved using the positioning guide and customized titanium plate. This will be assessed by superimposing the post-operative computed tomography (CT) scans onto the pre-operative virtual surgical plan. The difference will be reported as linear deviation, measured in millimeters (mm).
Assessment of Facial Symmetry (Malar Projection) — 6 months postoperatively Evaluation of aesthetic outcome and facial symmetry by assessing the malar projection. This will be measured clinically or via imaging (e.g., comparing the fractured side to the intact side). The outcome will be reported as the linear discrepancy or difference between the two sides, measured in millimeters (mm).
Trial sites (1)
Facility
City
Region
Status
department of oral and maxillofacial surgery, faculty of dentistry, Cairo university
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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